Aurobindo Pharma has announced that its tentatively approved ANDAs for Nevirapine Tablets 200 mg (ANDA 077521) and Nevirapine Oral Suspension 50mg/5mL (ANDA 077702) have received the final approval from the US Food & Drug Administration (US FDA). The products have a market size of approximately $ 125 million for the 12 months ending December 2011 according to IMS and will be launched soon.
Nevirapine Tablets 200mg and Oral Suspension 50mg/5mL are the generic equivalent of Boehringer Ingelheim Pharmaceutical’s Viramune Tablets 200mg and Oral Suspension 50mg/5mL. The products are indicated as part of antiretroviral (ARV) combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults.
Both the products have been approved out of Unit III formulations facility in Hyderabad, India Aurobindo now has a total of 151 ANDA approvals (125 Final approvals including 1 from Aurolife Pharma LLC and 26 Tentative approvals) from US FDA.
EP News Bureau – Mumbai